Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study has suspended participant recruitment.
(Modifications to the study design were required by the IRB)
Sponsor:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01832480
First received: April 4, 2013
Last updated: June 20, 2014
Last verified: June 2014

April 4, 2013
June 20, 2014
June 2013
December 2017   (final data collection date for primary outcome measure)
TV negative after treatment with either multi or single dose MTZ [ Time Frame: 1 month post treatment completion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01832480 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women

This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=1664). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect a vaginal swab for Gram stain testing and be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg BID 7-day dose (CDC alternative treatment regimen). All enrolled women will be asked to return for a follow-up visit at one month after baseline (window 3-13 weeks).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Vaginitis Trichomonal or Due to Trichomonas
  • Drug: MTZ 250 mg BID
    MTZ 250 mg BID
    Other Name: Multi-dose
  • Drug: MTZ 2 g
    MTZ 2 g
    Other Name: Single dose MTZ
  • Active Comparator: MTZ 2 g
    Single dose MTZ
    Intervention: Drug: MTZ 2 g
  • Experimental: MTZ 250 mg BID
    Multi dose MTZ
    Intervention: Drug: MTZ 250 mg BID

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
1664
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • English speaking
  • >= 18 years old (Crossroads, Delgado, ILH LSU OB/GYN); >=19 years old (JCDH)

Exclusion Criteria:

  • HIV-infected
  • unable to provide informed consent
  • pregnant
  • breast feeding
  • treated by their provider for BV (by Amsel criteria) at visit
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01832480
4042013
Yes
Patricia Kissinger, Tulane University Health Sciences Center
Tulane University Health Sciences Center
Not Provided
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
Tulane University Health Sciences Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP